ZinRom Nitrile examination gloves

K211719 · Changzhou Xingrong Medical Technology Co., Ltd. · LZA · Oct 6, 2021 · General Hospital

Device Facts

• Record ID: K211719
• Device Name: ZinRom Nitrile examination gloves
• Applicant: Changzhou Xingrong Medical Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 6, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Device Story

ZinRom powder-free nitrile examination gloves; blue color; available in S, M, L, XL sizes. Device features smooth surface and rolled rim at cuff. Used by healthcare examiners to prevent cross-contamination between patient and examiner. Single-use, non-sterile, disposable. Manufactured from nitrile rubber. Provides barrier protection during clinical examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM standards for freedom from holes (ASTM D5151), residual powder (ASTM D6124), physical properties (ASTM D412, D573), and dimensions (ASTM D6319). Biocompatibility testing performed per ISO 10993-5, 10993-10, and 10993-11.

Technological Characteristics

Material: Nitrile rubber. Form factor: Disposable, powder-free, blue, rolled-rim cuff. Sizes: S, M, L, XL. Standards: ASTM D6319-19, ASTM D3767-03, ASTM D5151-19, ASTM D6124-06, ASTM D573-04, ASTM D412-16, ASTM D7160-16. Biocompatibility: ISO 10993-5, 10993-10, 10993-11. Non-sterile.

Indications for Use

Indicated for use by examiners to prevent contamination between patient and examiner. Intended for single-use, non-sterile, over-the-counter application.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Powder Free Nitrile Patient Examination Gloves, Blue Color (K181106)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 6, 2021

Changzhou Xingrong Medical Technology Co. LTD Amber Pang Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai, 200071 China

Re: K211719

Trade/Device Name: ZinRom powder-free nitrile examination gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 6, 2021 Received: August 13, 2021

Dear Amber Pang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K211719

Device Name

Zinrom powder-free nitrile examination gloves

Indications for Use (Describe)

The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) summary-K211719

### l. Submitter

CHANGZHOU XINGRONG MEDICAL TECHNOLOGY CO., LTD. No. 528, Daqiaotou, Chaoyang Cunwei, Hengshanqiao Town, Economic Development District, Changzhou

Contact person: Ray Position: Sales Manager Tel.: [phone] E-mail: [e-mail]

Preparation date: Oct. 7, 2021

### II. Proposed Device

| Device Trade Name: | ZinRom powder-free nitrile examination gloves |
|--------------------|-----------------------------------------------|
| Common name: | Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LZA |
| Review Panel: | General Hospital |

### III. Predicate Devices

| 510(k) Number: | K181106 |
|-----------------|------------------------------------------------------------|
| Trade name: | Powder Free Nitrile Patient Examination Gloves, Blue Color |
| Common name: | Patient Examination Gloves |
| Classification: | Class I |
| Product Code: | LZA |
| Manufacturer | JiangSu Dongxin Medical Technology Co., Ltd. |

### IV. Device description

The propose devices is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are four sizes, includes small (S"), medium (M"), large (L"), X-large (XL") for optional. The gloves are provided with blue color. The examination glove is smooth surface and a rolled rim at the cuff edge.

The gloves are manufactured in accordance with the requirements of ASTM

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D6319-19 and Medical Glove Guidance Manual.

#### V. Indication for use

The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

### VI. Comparison of technological characteristics with the predicate devices

| Item | Standard | Proposed device<br>(K211719) | Predicate device<br>(K181106) | Comparison |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | - | ZinRom powder-free nitrile<br>examination gloves | Powder Free Nitrile<br>Patient Examination<br>Gloves, Blue Color | - |
| Product Code | - | LZA | LZA | Same |
| Regulation No. | - | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | - | Class I | Class I | Same |
| Powder free | - | Yes | Yes | Same |
| Indication for use | - | The nitrile<br>examination glove is<br>intended to be worn<br>on the hands of<br>examiner's to prevent<br>contamination<br>between patient and<br>examiner. This is a<br>single-use, powder- | Powder Free Nitrile<br>Patient Examination<br>Gloves, Blue Color is<br>a non-sterile<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's<br>hand or finger to<br>prevent | Same |
| | | free,<br>non-sterile device. | contamination<br>between patient<br>and<br>examiner. | |
| Main Material | ASTM D6319-19 | Nitrile rubber | Nitrile rubber | Same |
| Color | - | Blue | Blue | Similar* |
| Size | ASTM D6319-19 | Small, Medium,<br>Large, X large | Small, Medium,<br>Large, X large | Same |
| Palm width | ASTM D6319-19<br>Width: Range value -<br>S : Width: 80 ± 10 mm<br>M : Width: 95 ± 10 mm<br>L : Width: 110 ± 10<br>mm<br>XL : Width: 120 ± 10<br>mm | Small (83-87 mm)<br>Medium (97-98 mm)<br>Large (103-109 mm)<br>X large (118-120<br>mm) | Small (76-90mm)<br>Medium (89-102mm)<br>Large (108-119mm)<br>X large (115-128mm) | Similar Minor<br>difference<br>of palm width<br>does not affect<br>the intended<br>use |
| Length | ASTM D6319-19<br>Length: Range value -<br>S: Length : 220mm<br>min,<br>M : Length : 230mm<br>min | S (238-245 mm)<br>M (238-247 mm)<br>L (241-248 mm)<br>XL(231-248 mm) | 232 mm min for all<br>size | Similar<br>The length of<br>the predicate<br>device is shorter<br>than the<br>subject's. |
| | L : Length : 230mm<br>min,<br>XL : Length : 230mm<br>min, | | | |
| Thickness | ASTM D6319-19<br>For all size: Finger:<br>0.05 min<br>Palm: 0.05 min | Palm: 0.05mm min<br>Finger: 0.05mm min | Thickness (mm) min:<br>Palm: 0.08mm<br>Finger tip : 0.08mm | Similar<br>The thickness of<br>the subject<br>device is thinner<br>than the<br>predicates |
| Freedom from<br>holes | ASTM D5151-19<br>ASTM D6319-19<br>Inspection Level I<br>AQL2.5 | Inspection Level I<br>AQL2.5, and<br>Accept criteria Ac 10,<br>Re 11.<br>Pass. | 1) Inspection<br>Level I<br>AQL2.5,and<br>Accept/Reject<br>criteria of 10/11<br>2) Water leakage<br>test: 5<br>noncompliance is<br>allowed | Similar |
| Physical<br>Properties<br>(before aging) | ASTM D6319-19<br>ASTM D412-16<br>ASTM D573-04(2019)<br>Before Aging Range:<br>Tensile Strength<br>min: > 14 Mpa<br>Ultimate Elongation | Before aging:<br>Elongation: 500-<br>550%<br>Tensile Strength: 16-<br>24 MPa | Before aging:<br>Elongation: 550-<br>600%<br>Tensile Strength: 18-<br>25 MPa | Similar Only the<br>different<br>standard<br>version.<br>The<br>requirements of<br>physical<br>properties given<br>in the standard |
| | Min: 500% | | | are the same. |
| Physical<br>Properties (after<br>aging) | ASTM D6319-19<br>ASTM D412-16<br>ASTM D573-04(2019)<br>After Aging Range:<br>Tensile Strength min: ><br>14 Mpa Ultimate<br>Elongation Min: 400% | After aging:<br>Elongation: 450-<br>520%<br>Tensile Strength: 15-<br>22 MPa | After aging:<br>Elongation: 450-<br>570%<br>Tensile Strength: 17-<br>22 MPa | Similar Only the<br>different<br>standard<br>version.<br>The<br>requirements of<br>physical<br>properties given<br>in the standard<br>are the same. |
| Powder residual | ASTM D6319-19<br>ASTM D6124-06(2017)<br>Range:<br>< 2 mg/glove | ≤ 0.4 mg/gloves | 1) Checked on 5pcs<br>sub-samples (N=5).<br>2) Result as following:<br>Mean: 0.1mg/pcs | Similar |
| Sterility | - | Non-sterile | Non-sterile | Same |
| For single use | Medical Glove<br>Guidance Manual -<br>Labelling | Yes | Yes | Same |
| Type of use | - | Over the counter use | Over the counter use | Same |
| Shelf-life | ASTM D7160-16 | 3 years | NA | Different |
| | | 510(k) Summary | | |
| Biocompatibility<br>- Skin<br>Sensitization<br>Test | ISO 10993-10:2010 | Under the test<br>condition of study not<br>an sensitizer | Under the test<br>condition of study not<br>an sensitizer | Same |
| Biocompatibility<br>- Skin Irritation<br>Test | ISO 10993-10:2010 | Under the test<br>condition of study not<br>an irritant | Under the test<br>condition of study not<br>an irritant | Same |
| Biocompatibility<br>- Cytotoxicity<br>Test | ISO 10993-5:2009 | Under the test<br>conditions, the test<br>article was shown<br>potential<br>toxicity to L-929<br>cells. | Under the test<br>conditions, the test<br>article was non<br>cytotoxic to L-929<br>cells. | Different |
| Biocompatibility<br>- acute systemic<br>toxicity Test | ISO 10993-11:2017 | Under the<br>condition of acute<br>systemic toxicity test,<br>the test article did not<br>show acute systemic<br>toxicity in vivo. | Unknown | Different |

Table 1 Comparison of Patient Examination Glove

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510(k) Summary

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*As above comparison, the difference in the dimensions and reference standard version of the subject and predicate device does not raise additional questions for safety and effectiveness of the device. The biocompatibility test and performance test of the subject devices have been performed on the final finished device. The test results shows pass the requirements.

#### VII. Non-Clinical Testing

Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.

- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical ● Application
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions .
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical ● Gloves
- ASTM D573-04(2019), Standard Test Method for Rubber—Deterioration in an Air ● Oven
- ASTM D412-16, Standard Test Methods for Vulcanized Rubber and ● Thermoplastic Elastomers-Tension
- ASTM D7160-16, Standard Practice for Determination of Expiration Dating for . Medical Gloves
- . ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For . Irritation And Skin Sensitization
- ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for . systemic toxicity

| Test Method | Purpose | Acceptance<br>Criteria | Results |
|-----------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D5151<br>ASTM D6319-19 | Testing for Freedom<br>from holes | Inspection Level I<br>AQL2.5, and<br>Accept criteria Ac<br>10, Re 11. | Pass. No water<br>leakage is<br>inspected form 200<br>samples |
| ASTM D6124-<br>06(2017)<br>ASTM D6319-19 | Determine the<br>powder<br>residue for powder<br>free<br>gloves | < 2 mg/glove | ≤ 0.4 mg/gloves |
| 510(k) Summary | | | |
| ASTM D412-16<br>ASTM D573-04(2019)<br>ASTM D6319-19 | Testing for Physical<br>property<br>characteristics | After Aging Range:<br>Tensile Strength<br>min: > 14 Mpa<br>Ultimate Elongation<br>Min: 400%<br>After Aging Range:<br>Tensile Strength<br>min: > 14 Mpa<br>Ultimate Elongation<br>Min: 400% | Before aging:<br>Elongation: 500-<br>550%<br>Tensile Strength:<br>16-24 Mpa<br>After aging:<br>Elongation: 450-<br>520%<br>Tensile Strength:<br>15-22 MPa |
| ASTM D412-16<br>ASTM D573-04(2019)<br>ASTM D6319-19 | Testing For physical<br>dimensions<br>specification | Length for size (S);:<br>220 mm min.<br>Length for size (M,<br>L,XL): 230 mm min.<br><br>Width: 80±10 mm<br>for S; 95±10 mm for<br>M; 110±10 mm for<br>L; 120±10 mm for<br>XL.<br>Finger Thickness:<br>≥0.05 mm;<br>Palm Thickness:<br>≥0.05 mm;<br>All acceptance<br>criteria above meet<br>the<br>requirements in<br>Table 1 Dimensions<br>and<br>Tolerances of ASTM<br>D6319 | Length of Size S:<br>238-245 mm;<br>Width of Size S: 83-<br>87 mm;<br>Palm Thickness of<br>Size S: ≥0.05 mm;<br>Finger Thickness of<br>Size S: ≥0.05 mm.<br><br>Length of Size M:<br>238-247 mm;<br>Width of Size M: 97-<br>98 mm;<br>Palm Thickness of<br>Size M: ≥0.05 mm;<br>Finger Thickness of<br>Size M: ≥0.05 mm.<br><br>Length of Size L:<br>241-248 mm;<br>Width of Size L:<br>103-109 mm;<br>Palm Thickness of<br>Size L: ≥0.05 mm;<br>Finger Thickness of<br>Size L: ≥0.05 mm.<br><br>Length of Size XL:<br>231-248 mm;<br>Width of Size XL:<br>118-120 mm;<br>Palm Thickness of<br>Size XL: ≥0.05 mm;<br>Finger Thickness of<br>Size XL: ≥0.05 mm. |
| ISO 10993-10:2010 | Evaluate the<br>endpoint of<br>irritant for | The response of the<br>test article extract is<br>negligible. | Under the test<br>condition of study<br>not an sensitizer. |
| | biocompatibility | | 510(k) Summary |
| | Evaluate the<br>endpoint of<br>sensitization for<br>biocompatibility | The test article<br>showed no evidence<br>of causing delayed<br>dermal contact<br>sensitization. | Under the test<br>condition of study<br>not an irritant. |
| ISO 10993-5:2009 | Evaluate the<br>endpoint of<br>Cytotoxicity for<br>biocompatibility | The test article<br>showed no evidence<br>of Cytotoxicity from<br>the extract. | Under the test<br>conditions, the test<br>article was shown<br>potential<br>toxicity to L-929<br>cells. |
| ISO 10993-11:2017 | Evaluate the<br>endpoint of<br>Systemic<br>Cytotoxicity<br>for biocompatibility | The test article<br>showed no evidence<br>of systemic toxicity<br>from the extract. | Under the<br>condition of acute<br>systemic toxicity<br>test, the test article<br>did not show acute<br>systemic toxicity in<br>vivo. |

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## VIII. Clinical Testing

No clinical study is included in this submission.

### IX. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.